Merck Provides Regulatory Update on Investigational Medicine Sugammadex Injection

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Merck (MRK) Presents Data from VYTORIN Exploratory Analysis

March 16, 2015 3:35 PM EDT

Merck (NYSE: MRK) announced results from a pre-specified exploratory analysis of the investigational IMPROVE-IT study of more than 18,000 patients presenting with acute coronary syndromes. The new analysis shows that VYTORIN (ezetimibe/simvastatin) which combines simvastatin with the non-statin ZETIA® (ezetimibe) reduced total (defined as initial and recurrent) cardiovascular events by 9% compared to simvastatin alone (incidence-rate ratio [IRR] 0.91, 95% CI 0.85-0.97, p=0.007; by treatment group, 4,562 vs. 4,983 total events, respectively). These data were presented as part of this afternoons late-breaking featured clinical research session at the 2015 American College of Cardiology Scientific Sessions.

The results on the... More

Merck (MRK) Announces Cancellation of FDA Committee Meeting for Sugammadex Injection NDA Review

March 13, 2015 4:03 PM EDT

Merck (NYSE: MRK) said it was informed today that the U.S. Food and Drug Administration (FDA) has cancelled the meeting of the Anesthetic and Analgesic Drug Products Advisory Committee scheduled for March 18, 2015. The committee had planned to discuss the resubmission of the New Drug... More